The Blind Spots GMP Audits Miss, and How We Eliminate Them Without CAPEX

Quality Risks in Chemical Manufacturing Often Hide Between the Data Points

𝗪𝗲 𝗨𝗻𝗹𝗲𝗮𝘀𝗵 𝗛𝗶𝗱𝗱𝗲𝗻 𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗣𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗧𝗵𝗿𝗼𝘂𝗴𝗵 𝗢𝘂𝗿 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗣𝗹𝗮𝘁𝗳𝗼𝗿𝗺 — 𝗮𝗻𝗱 𝗗𝗲𝗰𝗿𝗲𝗮𝘀𝗲 𝗧𝗵𝗲 𝗥𝗶𝘀𝗸 𝗢𝗳 𝗦𝘂𝗽𝗽𝗹𝘆𝗶𝗻𝗴 𝗖𝗵𝗲𝗺𝗶𝗰𝗮𝗹𝘀.

Whenever manufacturing processes are not produced by 𝗰𝗮𝗽𝘁𝘂𝗿𝗶𝗻𝗴 𝘁𝗵𝗲 𝘃𝗮𝗹𝘂𝗲 𝗼𝗳 𝗱𝗮𝘁𝗮, even the best audited manufacturing processes will still possess inherent quality risks.

Under current GMP rules, only 𝘀𝗲𝗹𝗲𝗰𝘁𝗲𝗱 𝗽𝗼𝗶𝗻𝘁𝘀 during the manufacturing process are audited.

Many 𝗯𝗹𝗮𝗰𝗸 𝗯𝗼𝘅𝗲𝘀 between these points remain — and these blind spots can lead to hidden quality risks.

𝗪𝗲 𝗲𝗺𝗽𝗼𝘄𝗲𝗿 𝗼𝘂𝗿 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀 𝘁𝗼 𝗴𝗲𝘁 𝗿𝗶𝗱 𝗼𝗳 𝘁𝗵𝗲𝘀𝗲 𝗯𝗹𝗶𝗻𝗱 𝘀𝗽𝗼𝘁𝘀 by harvesting the insights of the data they already have — 𝗮𝗻𝗱 𝘄𝗶𝘁𝗵𝗼𝘂𝘁 𝗻𝗲𝗲𝗱 𝘁𝗼 𝗶𝗻𝘃𝗲𝘀𝘁 𝗶𝗻 𝗖𝗔𝗣𝗘𝗫.

In this way, their manufacturing becomes 𝗺𝗼𝗿𝗲 𝗿𝗼𝗯𝘂𝘀𝘁, 𝗺𝗼𝗿𝗲 𝗿𝗲𝗽𝗿𝗼𝗱𝘂𝗰𝗶𝗯𝗹𝗲, 𝗮𝗻𝗱 𝗺𝗼𝗿𝗲 𝗲𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁 at the same time.

𝗛𝗶𝗴𝗵𝗲𝘀𝘁 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗶𝘀 𝗼𝘂𝗿 𝗺𝗶𝘀𝘀𝗶𝗼𝗻.

We believe 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 is one essential part of the solution to realize it.